MAUDE Adverse Event Report: BD QUINCKE; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Catalog Number 405161

Device Problem Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2016

Event Type  malfunction  

Event Description

Procedure - lumbar puncture.In testing the bd spinal needle before the procedure, the practitioner was unable to reinsert the needle into the sheath.Tested another needle from the same lot number and could not reinsert the needle into the sheath.Another brand spinal needle used to perform the procedure.

• Brand Name: QUINCKE
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): BD; 5859 farinon dr. ste. 200; san antonio TX 78249
• MDR Report Key: 5778369
• MDR Text Key: 49091523
• Report Number: 5778369
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 405161
• Device Lot Number: 5106650
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1